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Emergent BioSolutions Inc Announces Initiation Of Phase 2 Study In Pursuit Of Post-Exposure Prophylaxis Indication For BioThrax

Tuesday, 22 Jan 2013 07:00am EST 

Emergent BioSolutions Inc announced the initiation of a Phase 2 study designed to evaluate non-interference of BioThrax (Anthrax Vaccine Adsorbed) when administered in conjunction with antibiotics. This non-interference study will be used to support a supplemental Biologics License Application seeking licensure of a Post-Exposure Prophylaxis (PEP) indication for BioThrax to be used in combination with antibiotics in people suspected to have been exposed to anthrax spores. Currently, BioThrax is licensed for a pre-exposure prophylaxis indication only. The primary objective of this Phase 2, randomized, open label study is to evaluate any impact of the vaccine on ciprofloxacin by administering the antibiotic prior to and following the administration of a 3-dose series of BioThrax. The study, which will enroll 120 healthy adult volunteers and is being conducted in multiple sites within the U.S., will also provide additional safety data on the concurrent administration of ciprofloxacin and BioThrax. Preliminary data from this study are expected in the fourth quarter of 2013. 

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0.38 +1.70%
31 Oct 2014